[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-hairy-cell-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-hairy-cell-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100088621","phase-2-cladribine-and-rituximab-in-treating-patients-with-hairy-cell-leukemia-100088621",false,"NCT00412594","Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia","Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia","Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination\n* Patients with relapsed disease are eligible if they have had no more than one prior therapy\n* Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study\n* Performance status =\\\u003C 3\n* Creatinine less than or equal to 2.0 unless related to the disease\n* Bilirubin less than or equal to 3.0\n* Transaminases less than or equal 3 x upper limit of normal unless related to the disease\n* No prior investigational agent in the 4 weeks prior to initiation of therapy\n\nExclusion Criteria:\n\n* Unable or unwilling to sign the consent form\n* Known infection with human immunodeficiency virus (HIV), hepatitis B or C\n* Presence of active infection\n* Presence of central nervous system (CNS) metastases\n* New York Heart Association classification III or IV heart disease\n* Prior chemotherapy (last 4 weeks)","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.",[26,27],"Hairy Cell Leukemia","Recurrent Hairy Cell Leukemia","RECRUITING","2026-06-09",{"date":31,"type":32},"2026-06-11","ACTUAL",{"date":34,"type":32},"2004-06-10",{"date":36,"type":20},"2027-06-30",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100590261","phase-1-testing-the-combination-of-anti-cancer-drugs-tovorafenib-plus-rituximab-in-patients-with-hairy-cell-leukemia-100590261","NCT06965114","Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia","A Phase 1 Study of Combination Tovorafenib (DAY101) and Rituximab Treatment in Relapsed or Refractory Classical Hairy Cell Leukemia and Phase 2 Randomized Study Comparing Tovorafenib (DAY101) and Rituximab With Cladribine and Rituximab for Front-Line Treatment of Classical Hairy Cell Leukemia","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed diagnosis of classical hairy cell leukemia (HCL), including demonstration of BRAF V600E mutation by immunohistochemistry, molecular diagnostic testing, or polymerase chain reaction (PCR)\n* PHASE 1 ONLY: Prior therapy with at least one purine nucleoside analog-containing regimen (fludarabine, pentostatin, or cladribine) unless contraindicated. Prior vemurafenib alone is allowed in the relapsed\u002Frefractory cohort\n* PHASE 2 ONLY: No prior HCL-directed treatment for front-line cohort. The design of this cohort is such that the patients will need to be treatment naïve\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of tovorafenib (DAY101) or cladribine in combination with rituximab in patients \\\u003C 18 years of age, children are excluded from this study\n* Patients must meet indications for treatment of cHCL:\n\n  * Absolute neutrophil count \\\u003C 1,000\u002FmcL\n  * Platelets \\\u003C 100,000\u002FmcL\n  * Hemoglobin \\\u003C 10 g\u002FdL\n  * Recurrent infections\n  * Symptomatic and\u002For progressive extramedullary disease including lymph nodes and bone lesions\n  * Progressive or symptomatic splenomegaly or hepatomegaly\n  * Disease-related constitutional symptoms consisting of unexplained weight loss exceeding 10% body weight during the preceding 6 months, Cancer Therapy Evaluation Program (CTEP) active version of the Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or 3 fatigue, and\u002For fever \\> 100.5 F or night sweats for \\> 2 weeks without evidence of active infection\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%); ECOG performance status \\> 2 (Karnofsky \\\u003C 60%) will be allowed if considered due to HCL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (unless related to Gilbert's disease or HCL; patients with documented Gilbert's disease may be enrolled with sponsor approval provided total bilirubin is ≤ 2.0 x ULN)\n* Creatinine clearance (ClCr) ≥ 30 mL\u002Fmin\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load for \\> 6 months\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of \\\u003C 480 msec\n* The effects of tovorafenib (DAY101), cladribine, and rituximab on the developing human fetus are unknown. For this reason and because BRAF kinase inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use two forms of adequate contraception (including a highly effective birth control method in addition to a barrier method) during treatment prior to study entry and for the duration of study treatment participation and 12 months after the last dose of the study medication\n\n  * WOCBP should use effective non-hormonal contraception during treatment and for 12 months after the last dose of the study medication. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. For male patients with a female partner of childbearing potential, a condom should be used for contraception in addition to one of the highly effective contraception methods prior to the study, for the duration of study treatment, and 12 months after the last dose of the study medication. Male patients must not father a child or donate sperm while participating in this study\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LARs) may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Central nervous system (CNS) involvement with HCL is very rare, and therefore the biology of the disease in patients with CNS involvement may not be representative of the disease under study as a whole. Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression\n* Patients with HCL who are BRAF V600E mutation negative and those with the variant HCL\n* Patients with platelets \\\u003C 50,000\u002FmCL\n* Patients on warfarin and direct oral anticoagulants (due to risk of bleeding)\n* Patients who have not recovered from AEs as a result of prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* Patients who are receiving strong CYP2C8 inhibitors, inducers, and breast cancer resistance protein (BCRP) substrates with narrow therapeutic index\n* Patients who are pregnant, breastfeeding, and\u002For unwilling to use adequate contraception during the study period and for 12 months after completion of the study\n* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to tovorafenib (DAY101) or other agents used in the study, including those with a previous history of severe infusion-related reaction (anaphylaxis) with rituximab administration\n* Patients with known hypersensitivity to any of the study drugs\n* Patients with an inability to swallow oral medications or with gastrointestinal impairment\n* Live or live-attenuated vaccines within 28 days of randomization\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because tovorafenib (DAY101) is a BRAF kinase inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with tovorafenib (DAY101), breastfeeding should be discontinued if the mother is treated with tovorafenib (DAY101). These potential risks may also apply to other agents used in this study",{"count":49,"type":20},84,[51,23],"PHASE1","This phase I\u002FII trial tests the safety, side effects, and effectiveness of tovorafenib in combination with rituximab in patients with classical hairy cell leukemia (cHCL) that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory) and compares the effect of tovorafenib and rituximab to current standard treatment of cladribine and rituximab in cHCL patients that have not yet received treatment. Tovorafenib blocks certain proteins made by the mutated BRAF gene, which may help keep cancer cells from growing. It is a type of kinase inhibitor. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cladribine damages the cell's deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. Giving tovorafenib in combination with rituximab may be safe and tolerable and more effective than cladribine with rituximab in treating patients with untreated, recurrent or refractory cHCL.",[26,27,54],"Refractory Hairy Cell Leukemia","2026-06-02",{"date":57,"type":32},"2026-06-03",{"date":59,"type":32},"2026-05-29",{"date":61,"type":20},"2030-03-01",{"name":63,"class":64},"National Cancer Institute (NCI)","NIH",4,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100540006","phase-2-venetoclax-for-the-treatment-of-patients-with-relapsed-hairy-cell-leukemia-100540006","NCT06311227","Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia","A Phase 2 Study of Venetoclax in Relapsed Classic or Variant Hairy Cell Leukemia","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed HCL\u002FHCLv after purine analog therapy who are relapsed from or are ineligible for BRAF therapy and have not received prior venetoclax\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Total bilirubin ≤ 3 x institutional upper limit of normal (ULN) unless consistent with Gilbert's (ration between total and direct bilirubin \\> 5)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Serum creatinine ≤ 2.0 mg\u002FdL OR creatinine clearance ≥ 45 mL\u002Fmin\u002F1.73m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patients must have had no HCL\u002FHCLv treatment for ≥ 4 weeks prior to enrollment, and those with treatment \\> 4 weeks prior to enrollment must not be responding to their last treatment with decreasing tumor burden or improving disease related cytopenias\n* Patients must have a need for treatment due to absolute neutrophil count (ANC) \\\u003C 1\u002FnL, hemoglobin (Hgb) \\\u003C 10g\u002FdL, platelets (Plt) \\\u003C 100\u002FnL, symptomatic splenomegaly, HCL mass with short axis \\> 2cm outside or \\> 0.5 cm inside the CNS, HCL\u002FHCLv count \\> 5\u002FnL in blood or \\> 25\u002Fmm\\^3 in cerebrospinal fluid (CSF), HCL\u002FHCLv doubling time \\\u003C 6 months and increasing lytic or blastic bone lesions\n* The effects of venetoclax on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during treatment and for 30 days after the last dose of venetoclax. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception during treatment and for 30 days after the last dose of venetoclax\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Ability and willingness to swallow pills\n\nExclusion Criteria:\n\n* Patients who have received prior venetoclax\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because venetoclax is a B-cell lymphoma-2 (BCL-2) inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax\n* Malabsorption syndrome or other conditions that would interfere with intestinal absorption\n* Live attenuated vaccines should not be administered within 4 weeks prior to, during, or 30 days after study treatment and recovery has occurred",{"count":74,"type":20},20,[23],"This phase II trial tests how well venetoclax works in treating patients with hairy cell leukemia that has come back after a period of improvement (relapsed). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival.",[27,78],"Recurrent Hairy Cell Leukemia Variant","2026-05-12",{"date":81,"type":32},"2026-05-13",{"date":83,"type":32},"2024-12-16",{"date":85,"type":20},"2027-05-20",{"name":63,"class":64},21]